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Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Elizabeth A. Robertson ordered by Published Date Descending.
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Jones Day Global Privacy & Cybersecurity Update | Vol. 21
Data privacy- and security-related class actions appear to be on the rise, and effectively defending them requires the right mix of substantive and procedural knowledge.
Worldwide
11 Mar 2019
2
CNIL Provides Guidance On Formalities In Relation To Health Data Processing In Health Research Sector
On August 20, the CNIL provided guidance on the measures to be taken by health researchers who modify the initial purposes for data processing (source document in French).
France
8 Nov 2018
3
CNIL Adopts Five New Methods Of Reference In Health Care Sector
On July 16, the CNIL adopted five new Methods of Reference (MR-001 to MR-005) for the health care sector to simplify compliance procedures when processing personal data for health research purposes...
France
8 Nov 2018
4
New French Decree Clarifies The Scope Of Biomedical Research
French Decree n° 2017-884 of May 9, 2017, was adopted to implement certain provisions of the Legal Ordinance of June 16, 2016, with respect to biomedical research.
France
4 Jul 2017
5
EMA Calls For Public Consultation On Clinical Trial Protocol
The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014).
European Union
4 Jul 2017
6
Guidance For European MA Holders To Prepare For Brexit
The EMA has published a Q&A guidance for marketing authorization ("MA") holders of centrally authorized medicinal products to prepare for the United Kingdom's withdrawal from the European Union.
European Union
4 Jul 2017
7
FDA Reorganizes ORA Staff
The FDA envisions that these changes will result in a high level of technical expertise and more uniform application of the ORA's policies and processes.
United States
4 Jul 2017
8
Senators Urge The Administration To Certify Imports Of Prescription Drugs From Canada
This letter follows a previous request from February 14, 2017, that the same senators made to Secretary Price.
United States
4 Jul 2017
9
EMA Green Lights New EudraVigilance System For Adverse Reactions
The new and improved version of the EudraVigilance database will be launched on November 22, 2017.
European Union
4 Jul 2017
10
EU Medical Device Regulation 2017/745 And In Vitro Diagnostic Regulation 2017/746
Below is a high-level summary of some of the key changes brought by the MDR and IVDR to the regulatory framework applicable to medical devices.
European Union
4 Jul 2017
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